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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceTack Endovascular System (4F, 1.5-4.5mm)
Generic Namescaffold, dissection repair
Applicant
Philips Image Guided Therapy Corporation (formerly Intact)
6655 wedgwood road north, suite 105
maple grove, MN 55311
PMA NumberP190027
Date Received10/01/2019
Decision Date04/10/2020
Product Code QCT 
Docket Number 20M-1286
Notice Date 04/14/2020
Advisory Committee Cardiovascular
Clinical Trials NCT02942966
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use in mid/distal popliteal, tibial and peroneal arteries, ranging in diameter from 1.5 mm to 4.5 mm, for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 
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